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SUVOREXANT

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD UNIT III · Approved 2025-12-22

Drug application

FDA Application #

ANDA219386

Application type

Abbreviated New Drug Application (Generic)

Brand name

SUVOREXANT

Generic name

Suvorexant

Active ingredients

SUVOREXANT

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

HETERO LABS LTD UNIT III

First approval

2025-12-22

Source

Authoritative

Drugs@FDA application overview

Machine

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